Drug Approval Package

 Hyzaar (Losartan Potassium/Hydrochlorothiazide) Tablets
Company:  Merck and Co., Inc.
Application No.:  020387/S13, S15, & S27
Approval Date: 9/30/2003

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)

• Environmental Assessment (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) (PDF)

• Correspondence (PDF)  

Date created: April 04, 2002

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